Evaluation of Plaque Removal Efficacy and Patient Acceptability of Knotted Floss Technique in Type I Gingival Embrasures

NCT02931994 | Completed DMC

• 2 other identifiers: UttaranchalDMRIUTN U1111-1188-4175
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Removal and prevention of formation of dental plaque biofilms is one of the current hygiene regimen to prevent, reduce or even reverse the gingival and periodontal disease condition. In such endeavors of mechanical plaque removal, tooth-brushing and use of dental floss play an important role. Gomes et al have presented a modification in the use of knotted floss in wider embrasure areas. The modification in the dental floss has been done so as to increase the effective width of the floss. The purpose of this study is to compare the reduction of the clinical signs of plaque accumulation, gingival inflammation and gingival trauma in the area the knotted floss technique has been utilized versus the area where conventional flossing has been utilized in Type I gingival embrasures. Patients' acceptability of the knotted flossing technique will also be evaluated. This study is part of a larger study protocol involving different sample groups comparing the knotted floss technique with conventional dental flossing, use of interdental brushes and unitufted brushes in type II and type III embrasures as well.

Conditions

Complication of Personal Oral Hygiene

Keywords

dental floss; gingival embrasure; oral hygiene

Outcome Measures

Primary Outcomes (4)

• Rustogi modification of Navy Plaque Index - 6weeks

  Rustogi modification of Navy Plaque Index will be assessed at 6-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group A Phase 2, and Group B Phase 2

  6 weeks

• Lobene's Modified Gingival Index - 6weeks

  Lobene's Modified Gingival Index will be assessed at 6-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group A Phase 2, and Group B Phase 2

  6 weeks

• Barnett's Modified Papillary Bleeding Index - 6weeks

  Barnett's Modified Papillary Bleeding Index will be assessed at 6-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group A Phase 2, and Group B Phase 2

  6 weeks

• Gingival Trauma Index (as described by Carter-Hanson et al 1996)- 6weeks

  Gingival Trauma will be assessed at 6-weeks for all subjects in Group A Phase 1, Group B Phase 1, Group A Phase 2, and Group B Phase 2. The Gingival Trauma induced by improper flossing will be assessed by the technique described by Carter-Hanson et al 1996. All interdental areas of the facial and lingual surfaces of the gingiva will be examined for gingival lacerations and indentations, using a mouth mirror, light, and after gently air-drying the gingiva. A score of one (1) will be given to facial and lingual surface separately when floss trauma is identified as a demarcation line or laceration. A score of zero (0) will be recorded if no such trauma is present. The Gingival Trauma Index score per subject will be obtained by totalling all scores and dividing by number of sites examined.

  6 weeks

Secondary Outcomes (12)

• Rustogi modification of Navy Plaque Index - baseline

  baseline

• Lobene's Modified Gingival Index - baseline

  baseline

• Barnett's Modified Papillary Bleeding Index - baseline

  baseline

• Gingival Trauma Index (as described by Carter-Hanson et al 1996) - baseline

  baseline

• Rustogi modification of Navy Plaque Index - 2 weeks

  2 weeks

Other Outcomes (1)

• Patient satisfaction questionnaire

  14 weeks ( at end of study)

Study Arms (4)

Group A Phase 1

NO INTERVENTION

50% of sample are randomly assigned to Group A and are to utilise conventional flossing technique in the first phase of 6-weeks

Group B Phase 1

ACTIVE COMPARATOR

50% of sample are randomly assigned to Group B and are to utilise knotted floss technique in the phase 1 of 6-weeks

Other: Knotted floss technique

Group A Phase 2

ACTIVE COMPARATOR

After a washout period of 2 weeks, those from Group A will use the knotted floss technique for a period of 6 weeks.

Other: Knotted floss technique

Group B Phase 2

NO INTERVENTION

After a washout period of 2 weeks, those from Group B will use the conventional floss technique for a period of 6 weeks.

Interventions

Knotted floss technique OTHER

The subjects use the knotted floss technique. In this modification of conventional flossing technique, a knot is tied in the floss at any distance in the middle third of the floss length. The floss is inserted past the interdental contact point by the conventional finger flossing technique in the non-knotted area and then during the 'to and fro movement' on the tooth surface cervical to contact point, the knotted area is engaged through the embrasure (Gomes et al 2016)

Group A Phase 2; Group B Phase 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have one type I gingival embrasure in the premolar first molar area.
• full mouth Plaque Index score ≥1.8 (Silness and Loe 1964)
• full mouth Gingival Index ≥ 1.0 (Loe and Silness 1963)
• good general health,
• have all teeth present in quadrant being tested and opposing quadrant
• be available for a 14 week study period,
• be ready to abide with the study criteria,
• minimum education of grade 12

You may not qualify if:

• have used in previous 2months oral hygiene aids other than tooth-brushing like dental flossing, mouthwashes and water jet irrigating systems
• habit of unilateral mastication for ≥2 months,
• medical history of diabetes mellitus, hepatitis, pregnancy or requiring any antibiotic prophylaxis,
• having drug history in preceding two months of use of antibiotics, hormonal supplements, steroids, non steroidal anti-inflammatory medications, oral contraceptives or any drug that influence gingival tissue,
• taking part in any other clinical or drug trial including taking part in other study groups related to the evaluation of knotted floss technique,
• having physical handicap limiting the ability for oral hygiene and effective use of dental floss,
• had orthodontic treatment
• having gross dental caries
• having advanced periodontitis (more than one pocket ≥ 6mm),
• had active periodontal treatment like scaling, root planing, curettage, periodontal surgery in the previous 8weeks,
• had any adverse oral habit like smoking, tobacco chewing or habits of self gingival mutilation,
• had history of trauma or surgery to the jaws.
• teeth adjacent to the embrasure area selected are having proximal caries or gross occlusal caries, or having proximal restorations, crowns, onlays or inlays.

Sponsors & Collaborators

• Uttaranchal Dental & Medical Research Institute: lead

Study Sites (1)

Knotted Floss Study; Uttaranchal Dental and Medical Reserach Institute

Dehradun, Uttarakhand, 248140, India

Location

Related Publications (19)

• LOE H, THEILADE E, JENSEN SB. EXPERIMENTAL GINGIVITIS IN MAN. J Periodontol (1930). 1965 May-Jun;36:177-87. doi: 10.1902/jop.1965.36.3.177. No abstract available.

  PMID: 14296927 BACKGROUND

• Socransky SS. Relationship of bacteria to the etiology of periodontal disease. J Dent Res. 1970 Mar-Apr;49(2):203-22. doi: 10.1177/00220345700490020401. No abstract available.

  PMID: 4313844 BACKGROUND

• Lewis MW, Holder-Ballard C, Selders RJ Jr, Scarbecz M, Johnson HG, Turner EW. Comparison of the use of a toothpick holder to dental floss in improvement of gingival health in humans. J Periodontol. 2004 Apr;75(4):551-6. doi: 10.1902/jop.2004.75.4.551.

  PMID: 15152819 BACKGROUND

• Suomi JD. Prevention and control of periodontal disease. J Am Dent Assoc. 1971 Dec;83(6):1271-87. doi: 10.14219/jada.archive.1971.0471. No abstract available.

  PMID: 4940401 BACKGROUND

• Schmid MO, Balmelli OP, Saxer UP. Plaque-removing effect of a toothbrush, dental floss, and a toothpick. J Clin Periodontol. 1976 Aug;3(3):157-65. doi: 10.1111/j.1600-051x.1976.tb01863.x.

  PMID: 1067277 BACKGROUND

• Hansen F, Gjermo P. The plaque-removing effect of four toothbrushing methods. Scand J Dent Res. 1971;79(7):502-6. No abstract available.

  PMID: 5289846 BACKGROUND

• Kresch CH. Finger-manipulated and floss-holder flossing: a comparison of the habit formation. Gen Dent. 1976 Jul-Aug;24(4):35. No abstract available.

  PMID: 1065605 BACKGROUND

• Gjermo P, Flotra L. The effect of different methods of interdental cleaning. J Periodontal Res. 1970;5(3):230-6. doi: 10.1111/j.1600-0765.1970.tb00722.x. No abstract available.

  PMID: 4254187 BACKGROUND

• Schmid M. Plaque control. In: Carranza F, editor. Glickmn's clinical periodontology. 6th ed. Philadelphia: W.B Saunders Company; 1984. p. 689-690

  BACKGROUND

• Gomes A, Meru S, Rekhi A. Knotted floss technique. J Adv Res Dent Oral Health 2016;1(1):6-7

  BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Rustogi KN, Curtis JP, Volpe AR, Kemp JH, McCool JJ, Korn LR. Refinement of the Modified Navy Plaque Index to increase plaque scoring efficiency in gumline and interproximal tooth areas. J Clin Dent. 1992;3(Suppl C):C9-12.

  PMID: 1306676 BACKGROUND

• Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986 Jan-Feb;8(1):3-6. No abstract available.

  PMID: 3485495 BACKGROUND

• Barnett M, Ciancio S. and Mather M. The modified papillary bleeding index: comparison with gingival index during the resolution of gingivitis. J Prev Dent 1980; 6:135-138

  BACKGROUND

• Bergenholtz A, Brithon J. Plaque removal by dental floss or toothpicks. An intra-individual comparative study. J Clin Periodontol. 1980 Dec;7(6):516-24. doi: 10.1111/j.1600-051x.1980.tb02158.x.

  PMID: 6938530 RESULT

• Carter-Hanson C, Gadbury-Amyot C, Killoy W. Comparison of the plaque removal efficacy of a new flossing aid (Quik Floss) to finger flossing. J Clin Periodontol. 1996 Sep;23(9):873-8. doi: 10.1111/j.1600-051x.1996.tb00626.x.

  PMID: 8891940 RESULT

• Asadoorian J. Canadian dental hygienists association position statement on flossing. Can Jour Dent Hygienist. 2006;40(3):1-10

  RESULT

• Carr MP, Rice GL, Horton JE. Evaluation of floss types for interproximal plaque removal. Am J Dent. 2000 Aug;13(4):212-4.

  PMID: 11763934 RESULT

Study Officials

• Aaron F Gomes, MDS

  Uttaranchal Dental and Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof & Head, Dept of Periodontics & Oral Implantology

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: October 13, 2016
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

IN (1)